BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UROLUME ENDOPROSTHESIS

    MDR report key: 3072320 · Received April 17, 2013

    Report

    Report Number
    2183959-2013-00802
    Event Type
    Injury
    Date Received
    April 17, 2013
    Date of Event
    March 29, 2012
    Report Date
    March 19, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    MER
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE REGARDING THIS EVENT, IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DUE TO PT COMPLAINT OF INCONTINENCE AND PAIN, A LASER STONE FRAGMENTATION PROCEDURE OF AN ENCRUSTED STENT WAS PERFORMED AND THE ENTIRE STENT DEVICE WAS REMOVED. NO PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166309 UROLUME ENDOPROSTHESIS ENDOURETHRAL PROSTHESIS MER AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R